9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Investor Presentation (June 2022)
30 slides from 9 Meters Biopharma's investor presentation, Jun 30, 2022
Slide 1: Pioneering Novel Treatments with a one-tract mind
Pioneering Novel Treatments with a one-tract mind FOCUSED ON RARE AND UNMET NEEDS IN DIGESTIVE DISEASES AND UNIQUE GI B IOLOGY June 28 , 2022
Slide 2: Forward-looking statements
forward-looking statements This presentation includes forward-looking statements based upon the Company's current expectations. Forward- looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions, anticipated milestones
Slide 3: Vision and mission
Changing the world through novel therapeutic approaches that treat people with rare and debilitating conditions via unique gut related pathways. vision changing the world for patients mission Developing innovative treatments to liberate patients from rare and underserved diseases through our deep un
Slide 4: Investor highlights: 9 Meters at a glance
investor highlights 9 meters at a glance Focused on rare and debilitating diseases by modulating the biology of the GI tract vurolenatide Proprietary long-acting GLP-1 agonist for short bowel syndrome with Phase 3 initiation planned for 2H 2022 a straight-forward strategy Employing capital efficient
Slide 5: Leadership team
John Temperato PRESIDENT & CHIEF EXECUTIVE OFFICER Bethany Sensenig, MBA, CMA CHIEF FINANCIAL OFFICER Patrick H. Griffin, MD CHIEF MEDICAL OFFICER Sireesh Appajosyula, PharmD SVP, CORPORATE DEVELOPMENT & OPERATIONS Nir Barak, MD SVP, SCIENTIFIC AFFAIRS Matthew D. Bryant, PharmD VP, MEDICAL AFFAIRS S
Slide 6: 9 meters in circuitous length, but a straight-forward strategy
develop capital efficient & regulatory predicates acquire/ partner aligned to focus commercialize efficient US footprint; strategic ROW partnerships rare, unmet needs & unique GI biology digestive disease-centric, patient-focused • Acquire targeted clinical compounds • Agnostic within GI tract if ne
Slide 7: Pipeline: one tract with multiple meaningful opportunities
NOTE: All programs are New Chemical Entities. NOTE: All programs are globally licensed except NM-004, which excludes Asia, except for Japan. * 9 Meters Press release, June 21, 2022 **MIS-C = multisystem inflammatory syndrome in children clinical trial in collaboration with European Biomedical Resear
Slide 8: Vurolenatide: long-acting GLP-1 agonist
vurolenatide: long-acting glp-1 agonist Short Bowel Syndrome (SBS); Orphan Designation
Slide 9: Patients with SBS typically have compromised levels of GLP-1
patients with sbs typically have compromised levels of glp-1 Illustration of one phenotype of SBS with colon-in-continuity; Other phenotypes exist with and without colon-in-continuity 9 • GLP-1 is naturally produced in a portion of the ileum that is removed during surgical resection • Natural GLP-1
Slide 10: Reasons to believe
9 reasons to believe Vurolenatide has the potential to advance the treatment of SBS 1) Faster1 Onset of Action Within hours or days of dosing vs. weeks or Months with GLP-2 6) 15 years of patient experience with active molecule 7) Transient side effects vs. REMS with current GLP-2 2) Slows Gut Motil
Slide 11: Vurolenatide replaces GLP-1 and restores the ileal brake
vurolenatide replaces glp-1 and restores the “ileal brake” short bowel syndrome with glp-1 GLP-1 travels through the blood, which affects gut motility elsewhere in the body. Motility is slowed, allowing more time for nutrient uptake. Vurolenatide rapidly replaces physiological effects of missing GLP
Slide 12: Vurolenatide is XTENylated with ultra-long half-life
vurolenatide is XTENylatedTM with ultra-long half-life Asp HisGly Thr ThrSerPheGluGly Asp Leu Ser LysGlnMetGluGluAlaVal GluArg Phe Leu Ile GluTrpLeu ProLys GlyGly Ser Ser Gly GlyAlaProProSer • Dipeptidyl peptidase 4 cleaves native GLP-1 and GLP-2 in minutes • Exenatide still limited by half-life (2.
Slide 13: Vurolenatide open-label Phase 1b/2a trial results
vurolenatide open-label single-center phase 1b/2a trial results
Slide 14: Phase 1b/2a study: SBS clinical trial design
phase 1b/2a study: sbs clinical trial design *The study protocol called for an analysis of urine output; however, it proved difficult to measure in an ambulatory setting. open label, 2-dose, dose-escalation study of vurolenatide in adult patients with sbs Vurolenatide given twice, at 3 different dos
Slide 15: Phase 1b/2a trial: treatment-emergent adverse events
phase 1b/2a trial: treatment-emergent adverse events Vurolenatide was generally safe and well tolerated: 17 TEAEs were observed in 9 patients, 15 of which were mild, transient and self-limited without further intervention. The majority of TEAEs were GI-related (nausea and vomiting). 15 Study confirm
Slide 16: Phase 1b/2a efficacy: total stool output
phase 1b/2a efficacy: total stool output (tso) *Patient 6 did not receive a second dose. †The baseline prior to the second dose in this patient was substantially higher than the original baseline volume due to rapid increase in oral intake. 16
Slide 17: FDA response on planned Phase 2 program
fda response on initiated phase 2 program FDA Type C meeting communication supported plan to initiate Phase 2 study with vurolenatide for SBS using TSO as the primary efficacy outcome measure Multicenter, double-blind, double-dummy, randomized placebo-controlled trial; FDA has provided global anchor
Slide 18: VIBRANT Phase 2 study
VIBRANT phase 2 study VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT Study objectives, design & preliminary results
Slide 19: VIBRANT: Phase 2 SBS trial design & timeline
VIBRANT: phase 2 sbs trial design & timeline Timeline: preliminary results expected 2Q22 50 mg PBOGroup 1 Group 2 Group 3 Group 4 Study population: all comers (regardless of phenotype and/or PS requirement) 50 mg PBO 50 mg 100 mg PBO 100 mg PBO 100 mg 50 mg 50 mg 50 mg 50 mg 50 mg PBO PBO PBO PBO PB
Slide 20: VIBRANT trial objectives and enrollment
VIBRANT trial objectives and enrollment • Evaluate previous open label trial efficacy in placebo-controlled and blinded setting • Confirm overall tolerability and safety profile in placebo-controlled and blinded setting • Identify go-forward dose and dose regimen for Phase 3 • Design and execute pho
Slide 21: VIBRANT demographics, disposition and phenotype
VIBRANT demographics, disposition and phenotype • Demographics: • N = 11 • 3/8 (M/F) • Mean Age: 54.1; (44 – 67; min – max) • Race: Black/African American (2); White (9) • Ethnicity: Not Hispanic or Latino (11) • Study Disposition • No patient withdrew from the study in 11 patients • SBS anatomic ph
Slide 22: VIBRANT Phase 2 trial objectives met
VIBRANT phase 2 trial objectives met • Safety and tolerability Confirmed • No Adverse Event leading to early withdrawal • 2 SAEs – central catheter infections (Unrelated to Study Drug) • Efficacy Confirmed • Overall, 7/11 met definition for TSO Responder over the 6 weeks post randomization [Conserva
Slide 23: VIBRANT Phase 2 trial timeline & regulatory next steps
VIBRANT phase 2 trial timeline & regulatory next steps • Study remains ongoing and blinded to maximize EOP2 discussion value • FDA meeting granted for mid-third quarter 23
Slide 24: VIBRANT2 Phase 3 planning
VIBRANT2 phase 3 planning VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT - 2 Start-up timing & CRO selection
Slide 25: VIBRANT2 - Phase 3 start up and planning
VIBRANT2 - phase 3 start up and planning • Anticipated phase 3 start – Q4 2022 • All six VIBRANT phase 2 sites will be first to be initiated for phase 3 • Utilizing CRO with bona fide Rare Disease experience (with SBS experience in EU) • Feasibility for US & Canada identified multiple viable sites •
Slide 26: Vurolenatide: market opportunity
vurolenatide: market opportunity Short Bowel Syndrome (SBS); Orphan Designation
Slide 27: Short bowel syndrome: a debilitating orphan disease
short bowel syndrome: a debilitating orphan disease Results from massive resection of the small intestine due to recurrent Crohn’s disease, mesenteric vascular events, trauma, malignancy or complications from abdominal surgery1 Clinical consequences are far reaching • Includes malnutrition, diarrhea
Slide 28: The patient journey: short bowel syndrome
the patient journey: short bowel syndrome Sources: 1.) Messing et al. Long-term Survival and Parenteral Nutrition Dependence in Adult Patients with the Short Bowel Syndrome. Gastroenterology 1999. 2.) Winkler, Marion. Et al. An Exploration of Quality of Life and the Experience of Living with Home Pa
Slide 29: Vurolenatide is poised to address unmet needs in the SBS market
Vurolenatide is poised to address unmet needs in the SBS market 29 Degree of Malabsorption D e gr e e o f Fl u id / N u tr it io n al S u p p o rt Additional Oral Intake (hyperphagia) Parenteral Support • Gattex/Revestive (teduglutide) target population is limited to patients on parenteral support (
Slide 30: Contact information
8480 Honeycutt Road, Suite 120 Raleigh, NC 27615 Telephone: 1-919-275-1933 info@9meters.com www.9meters.com Twitter LinkedIn
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